Quotient Clinical / Developing a robust 14C preclinical and clinical study strategy: a simple plan to deliver a complex program of studies

Developing a robust 14C preclinical and clinical study strategy: a simple plan to deliver a complex program of studies

February/ March 2017

Speaker:

Iain Shaw, Director 14C Enabled Drug Development, Quotient Clinical

Data derived from a human ADME study are required globally as part of the registration packages for new medicines (e.g. NDA, MAA). While on the surface it would appear to be a simple clinical study to conduct, solving potential technical problems along with bringing together the numerous components is challenge and requires highly competent scientific capability and significant coordination of API radiochemistry, non clinical enabling studies, drug product formulation and manufacture, regulatory submission, clinical conduct, sample analysis and data reporting.

Join our free seminars to hear case studies describing the building blocks of a human ADME program and best practices for regulatory submissions.

Presentation: A complicated program made easy – simplifying the human ADME program

Iain Shaw, Director 14C Enabled Drug Development, Quotient Clinical

The building blocks of a human ADME study for regulatory submission

The Synthesis to Clinic approach to program integration

How a single study can deliver complete pharmacokinetic and metabolism knowledge